| アブストラクト | BACKGROUND: The accelerating global aging trend has positioned insomnia in the elderly as a major public health challenge. Although cognitive behavioral therapy is the first-line intervention, pharmacological treatment remains widely used. However, significant safety concerns exist regarding the use of traditional non-benzodiazepine sedative-hypnotics (nBZRAs) in older adults, while long-term real-world safety evidence for newer dual orexin receptor antagonists (DORAs) remains scarce. Addressing this evidence gap is critical for guiding safe medication use in the aging population. METHODS: We conducted a pharmacovigilance study utilizing the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering reports from the first quarter of 2004 to the second quarter of 2025. We included reports for patients aged >/=65 years where a target nBZRA or DORA was listed as the primary suspect drug. A comprehensive disproportionality analysis was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM), with stringent thresholds to minimize false positives. RESULTS: A total of 5,447 reports for elderly patients were analyzed. The study revealed distinct adverse event profiles between the two drug classes. nBZRAs, particularly eszopiclone, showed the strongest signals related to therapeutic failure (e.g., "Drug ineffective," "Insomnia") alongside a unique signal for "Dysgeusia". In contrast, DORAs exhibited strong and consistent signals for "Dream-abnormality" events concordant with their sleep-wake modulation mechanism, including "Nightmare," "Abnormal dreams," and "Hallucination". Notably, none of the studied drugs generated a statistically significant signal for "Fall" within this dataset. System Organ Class analysis showed that psychiatric and nervous system disorders had the highest incidence. CONCLUSION: These findings highlight distinct safety profiles: nBZRAs are linked to therapeutic failure and dysgeusia, while DORAs are associated with neuropsychiatric events such as nightmares and hallucinations. |
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